510(k) · Cleared
Recalled · 2007Uhr UNIVERSAL6HIP Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Feb 11, 1980 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it. It has been recalled 36 times.
- Decided
- Feb 11, 1980
- Review
- 12 days
- Class
- Class II
- Product code
- KWL
- Recalls
- 36
- Predicates
- 0
25 later devices descend from it, 6 citing it directly.
- This deviceK800207 Uhr UNIVERSAL6HIP ReplacementOsteonics Corp. · 1980
- Descendant · cites it directly · 10 of its ownK112019 Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK222632 UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
2011high 4 (2022) · low 0 (2013)2026
Most influential descendants
Showing 5 of 25 · See all- K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011 · cites it directly10descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 2 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 3 generations on6descendants
- K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800207 | Uhr UNIVERSAL6HIP Replacement | Osteonics Corp. | 1980 | — |
| +1 | K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup | Corentec Co., Ltd. | 2011 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +2 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +3 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +1 | K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup | 2011 | 10 |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | 2022 | 5 |
| K183114 | Corin BiPolar-i | 2019 | 3 |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | 2016 | 3 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
| K173455 | SurgTech Bipolar Head System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2007 | Not classified | Z-0621-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0626-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0642-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0643-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0644-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0622-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0627-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0628-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0629-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0636-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0639-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0623-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0624-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0631-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0632-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0635-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0645-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0647-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0651-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0652-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0653-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0654-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0655-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0625-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0630-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0633-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0634-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0637-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0638-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0640-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0641-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0646-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0648-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0649-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0650-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
| Oct 26, 2007 | Not classified | Z-0656-2008 | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
The 5 latest of 36 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112019 (Corentec Co., Ltd., 2011) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2007high 3 (2025) · low 0 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
2007high 32 (2025)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
2007high 36 (2007) · low 0 (2008)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
2007high 415 (2019) · low 11 (2007)2025
MAUDE reports naming product code KWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K800207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K800207: Uhr UNIVERSAL6HIP Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800207
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026